Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis
Completed · Phase 3
Conditions studied: Multiple Sclerosis
In brief
International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis
Key facts
- Study ID
- NCT02425644
- Run by
- Actelion
- People needed
- 1133
- Starts
- 2015-06-04
- Expected to finish
- 2019-05-16
- Last updated by the study team
- 2025-03-30
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male and female subjects aged 18 to 55 years with established diagnosis of MS McDonald 2010 with relapsing course from onset (i.e., RRMS and SPMS with superimposed relapses).
- Subjects must have active disease evidenced by one or more MS attacks with onset within the period of 12 to 1 months prior to randomization, or by two or more MS attacks with onset within the 24 to 1 months prior to randomization, or with one or more gadolinium-enhancing (Gd+) lesion(s) of the brain on an MRI performed within 6 months prior to randomization.
- Enrolled subjects must be ambulatory (EDSS score of up to 5.5 inclusive) and may be treatment-naïve or previously treated with MS disease modifying therapy.
You may not qualify if…
- Subjects with significant medical conditions or therapies for such conditions (e.g., cardiovascular, pulmonary, immunological, hepatic,ophthalmological conditions) or lactating or pregnant women are not eligible to enter the study.
- Subjects with contraindications to MRI or with clinically relevant medical or surgical conditions that, in the opinion of the investigator, would put the subject at risk by participating in the study are not eligible to enter the study.
Where it is running
- Investigator Site 8311 — Pomona, California, United States
- Investigator Site 8036 — Denver, Colorado, United States
- Investigator Site 8065 — Ormond Beach, Florida, United States
- Investigator Site 8018 — Tampa, Florida, United States
- Investigator Site 8013 — Indianapolis, Indiana, United States
- Investigator Site 8040 — Raleigh, North Carolina, United States
- Investigator Site 8006 — Columbus, Ohio, United States
- Investigator Site 8015 — Franklin, Tennessee, United States
- Investigator Site 8042 — Orem, Utah, United States
- Investigator Site 3605 — Grodno, Belarus
- Investigator Site 3603 — Minsk, Belarus
- Investigator Site 3602 — Minsk, Belarus
- Investigator Site 3606 — Vitebsk, Belarus
- Investigator Site 3604 — Vitebsk, Belarus
- Investigator Site 9104 — Sarajevo, Bosnia and Herzegovina
- Investigator Site 2709 — Plovdiv, Bulgaria
- Investigator Site 2711 — Sofia, Bulgaria
- Investigator Site 2702 — Sofia, Bulgaria
- Investigator Site 2707 — Sofia, Bulgaria
- Investigator Site 2701 — Sofia, Bulgaria
- Investigator Site 2708 — Sofia, Bulgaria
- Investigator Site 2703 — Sofia, Bulgaria
- Investigator Site 8102 — Edmonton, Alberta, Canada
- Investigator Site 8120 — Victoria, British Columbia, Canada
- Investigator Site 8045 — Carlsbad, California, United States
Full record on ClinicalTrials.gov
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